Editor’s Choice

Complexity of intravenous iron nanoparticle formulations: implications for bioequivalence evaluation

Intravenous iron formulations are a class of complex drugs that are commonly used to treat disease states associated with iron deficiency and anemia, with the iron–sucrose reference listed drug Venofer® being the treatment of choice in the United States but a number of iron–sucrose similars or copies proliferating in global markets. This scholarly review examines emerging data demonstrating that these follow-on iron–sucrose similars exhibit safety and efficacy profiles that differ from the reference listed drug, highlighting potential issues with these generic drugs and the difficulties of demonstrating bioequivalence for non-biological complex drug formulations.

NYAS Editor's Choice

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